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510(k) Data Aggregation

    K Number
    K240165
    Device Name
    Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer
    Manufacturer
    Wenzhou Longwan Medical Device Factory
    Date Cleared
    2024-03-20

    (58 days)

    Product Code
    DXQ, DXO, LDE
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    Wenzhou Longwan Medical Device Factory

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on new borns, infants, children, young adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.
    Device Description
    The ANEROID SPHYGMOMANOMETER and ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE are manual blood pressure monitor used to measure blood presure.It consists of a cuff,a inflation bulb,a pressure gauge, an air valve and a stethoscope(optional). Cuff: The cuff is made of a durable fabric and is wrapped around the upper arm of the patient. It inflates and deflates during the measurement process. The material of outside layer is nylon cloth. Inflation Bulb: The inflation bulb is a rubber bulb that connects to the cuff and is used to manually inflate the cuff with air. The material is Neoprene or Silicon rubber or Nature latex or PVC. Pressure Gauge: The pressure gauge is a circular dial with a needle that indicates the pressure within the cuff. It is calibrated in millimeters of mercury (mmHg) and shows the systolic and diastolic blood pressure readings. The material is Aluminum or ABS. Air Valve: The valve is a control mechanism that allows for the release of air from the cuff once the measurement is complete. Stethoscope: Although not a part of the device itself, a stethoscope is typically used in conjunction with an Aneroid Sphygmomanometer to listen for the blood flow sounds, known as Korotkoff sounds, in the brachial artery during the measurement. Three model are single head Stethoscope(Model: TY-S01),Dual Head Stethoscope(Model: TY-S05) and Spraque Rappaport Stethoscope(Model: TY-S04) individually.These stethoscopes are listed in FDA database.
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